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Roche Pharmaceuticals

MabThera Maintenance Therapy Helps Non-Hodgkin's Lymphoma Patients Live for Years Longer Without Their Disease Progressing

Basel, Switzerland (ots/PRNewswire)

  • For non-US and non-UK Media Only
  • Long-term Results From a Phase III Study Highlight the Beneficial Role of MabThera in Patients With Recurrent or Resistant Disease
Data presented at the 50th Annual Meeting of the American Society
of Hematology (ASH) today confirmed that patients with recurrent or
resistant follicular non-Hodgkin's lymphoma (NHL) receiving MabThera
maintenance therapy after initial treatment with (immuno)
chemotherapy live almost 2.5 years longer without their disease
progressing than those not receiving maintenance treatment,
representing a threefold increase in progression-free survival time.
Six-year follow up results from a study conducted by the European
Organisation for Research and Treatment Cancer (EORTC) study group,
show that patients with recurrent or resistant follicular NHL who
were given MabThera maintenance treatment after their initial
treatment with (immuno) chemotherapy had a median response of 3.7
years compared to 1.3 years for those who did not receive maintenance
treatment. The results also indicate that patients treated with
MabThera in combination with chemotherapy experience better complete
response (CR) rates compared to patients treated with the
chemotherapy combination cyclophosphamide, doxorubicin, vincristine
and prednisolone (CHOP) alone (29% vs 16%).
"These results show that MabThera maintenance therapy can help
patients with follicular NHL return to their 'normal' daily
activities by offering years of extra time between relapses", said
Professor Marinus van Oers of the University of Amsterdam and lead
investigator of the study. "This is an important advance in the
treatment of this still incurable form of NHL that will be welcomed
by patients and physicians alike," he added.
NHL affects one million people worldwide. Follicular NHL,
representing about 25% of patients, is a slow developing but serious
cancer of the lymphatic system. It is currently considered incurable.
About the study
EORTC 20981 is a phase III study designed to evaluate the role of
MabThera in the treatment of patients with relapsed and refractory
follicular NHL during the induction and maintenance phases. It
provides a six-year follow up of the study that was originally
published in Blood in November 2006. At that time the median follow
up had been 33 months. The primary endpoints were response rate for
the induction phase and progression-free survival (PFS) for the
maintenance phase. The study involved 465 patients during the
induction phase (234 R-CHOP; 231 CHOP) and 334 patients during the
maintenance phase (167 R; 167 observation). The results show that
patients treated with MabThera and CHOP induction therapy experience
better complete response (CR) rates compared to patients treated with
CHOP alone (29% vs 16%). In addition, the results show that patients
treated with MabThera during the maintenance phase experience
improved PFS compared to patients observed (median 3.7 years vs 1.3
years). While improved PFS with MabThera does not translate into
statistically significant overall survival advantages, this may be
explained by the fact that 41% of patients received MabThera as (part
of) salvage therapy. MabThera maintenance was also associated with a
significant increase in grade 3/4 infections (9.7 % vs 2.4 %). Only 4
% of patients had to discontinue maintenance because of toxicity
(mostly recurrent infections).
All trademarks used or mentioned in this release are legally
protected.
    Further Information:
    - Roche in Oncology:
      http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf
    - Lymphoma: http://www.lymphoma-net.org
    - The Lymphoma Coalition: http://www.lymphomacoalition.org
    - Cancer: http://www.health-kiosk.ch/start_krebs.htm
    - World Health Organization: http://www.who.int
    For more information, please contact:
    Peter Bayliss
    Roche
    Mobile: +41-7957-25193
    Email:  peter.bayliss@roche.com
    Amber Bradbury
    Ketchum
    Phone: +44-7793-681615
    Email:  amber.bradbury@ketchum.com

Contact:

For more information, please contact: Peter Bayliss, Roche, Mobile:
+41-7957-25193, Email: peter.bayliss@roche.com; Amber Bradbury,
Ketchum, Phone: +44-7793-681615, Email: amber.bradbury@ketchum.com

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